Clinical trial • Phase IV • Other
METHYLPREDNISOLONE ACETATE; LIDOCAINE HYDROCHLORIDE for Arthritis of the temporomandibular joint
Phase IV trial of METHYLPREDNISOLONE ACETATE; LIDOCAINE HYDROCHLORIDE for Arthritis of the temporomandibular joint.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Arthritis of the temporomandibular joint
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 14-12-2023
- First CTIS Authorization Date
- 22-03-2024
Trial design
Randomised, natriumklorid b. braun 9 mg/ml innrennslislyf, lausn (sodium chloride 9 mg/ml) solution for injection - comparator; dose/schedule not specified in record-controlled Phase IV trial across 1 site in Sweden.
- Randomised
- Yes
- Comparator
- Natriumklorid B. Braun 9 mg/ml innrennslislyf, lausn (sodium chloride 9 mg/ml) solution for injection - comparator; dose/schedule not specified in record
- Target Sample Size
- 60
- Trial Duration For Participant
- 180
Eligibility
Recruits 60 No vulnerable population selected. Participants must give written informed consent themselves and must understand Swedish orally and in writing. No assent or parental consent procedures for minors are described (study includes adults ≥18 years)..
- Vulnerable Population
- No vulnerable population selected. Participants must give written informed consent themselves and must understand Swedish orally and in writing. No assent or parental consent procedures for minors are described (study includes adults ≥18 years).
Inclusion criteria
- {"criterion_text":"- age ≥ 18 years"}
- {"criterion_text":"- TMJ clinical arthritis in one or both joints"}
- {"criterion_text":"- Understand swedish orally and in writing"}
- {"criterion_text":"- Given written consent to participate in the study"}
- {"criterion_text":"- Has been given information about the condition and treatment in postural exercises"}
Exclusion criteria
- {"criterion_text":"- Allergy to methyl-prednisolone or any other content in the drug"}
- {"criterion_text":"- Fungusinfection that affect the body"}
- {"criterion_text":"- Local virus- or/and bacteriainfection"}
- {"criterion_text":"- TMJ joint surgery or trauma during the last two years"}
- {"criterion_text":"- Cortisone injection in the TMJ the last 3 months"}
- {"criterion_text":"- Patients whose condition can be related to other diseases for instance auto-immune disease, neurologic disease, myalgia or tooth ache"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Pain relief will be measured with 100 mm VAS-scale at baseline, 1, 3 and 6 months after treatment","definition_or_measurement_approach":"Pain measured using a 100 mm Visual Analog Scale (VAS) at baseline, and at 1, 3 and 6 months after treatment."}
Secondary endpoints
- {"endpoint_text":"- The maximal mouth opening will be measured in mm at baseline, 1, 3 and 6 months after treatment with cortisoneinjection or arthrocentesis","definition_or_measurement_approach":"Maximal mouth opening measured in millimetres (mm) at baseline, and at 1, 3 and 6 months after treatment."}
- {"endpoint_text":"- Psychosocial factors measurements will be collected at base examination in the clinic and the patients will have to fill out a questionnaire containing The Patient Health Questionnaire (PHQ-9 and PHQ-15), GAD-7, PCS. In every visit JFLS and GCPS will be measured through another questionnaire.","definition_or_measurement_approach":"Psychosocial factors assessed via questionnaires at baseline: PHQ-9, PHQ-15, GAD-7, PCS; at each visit JFLS and GCPS measurements recorded via questionnaires."}
- {"endpoint_text":"- Presence of degenerative bone changes will be examined by oral radiologist and graded as 0 (no bony changes) or 1 (bone changes in the TMJ).","definition_or_measurement_approach":"Oral radiologist assesses CT at baseline and grades cortical bone changes on a two-point scale: 0 = no change, 1 = loss of cortical bone."}
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 24
- Consent Approach
- Written informed consent required from each participant. Participants must understand Swedish orally and in writing. No assent or parental consent procedures described; consent documentation/language is Swedish.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Sweden
- Earliest CTIS Part Ii Submission Date
- 26-02-2024
- Latest Decision Or Authorization Date
- 22-03-2024
- Processing Time Days
- 25
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Folktandvarden Vastra Gotalandsregionen
- Department Name
- Specialistkliniken för bettfysiologi Göteborg - Medicinaregatan 12A, 413 90 Göteborg
- Contact Person Name
- Birgitta Johansson Cahlin
- Contact Person Email
- birgitta.johansson-cahlin@vgregion.se
Sponsor
Primary sponsor
- Full Name
- Vaestra Goetalandsregionen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Depo-Medrol cum Lidocain 40 mg/ml / 10 mg/ml injektionsvätska, suspension
- Active Substance
- METHYLPREDNISOLONE ACETATE; LIDOCAINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Marketing authorised (authorisationCountryCode: FI, marketingAuthNumber: 9607)
- Maximum Dose
- 1 ml
- Investigational Product Name
- Natriumklorid B. Braun 9 mg/ml innrennslislyf, lausn
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Marketing authorised (authorisationCountryCode: IS, euMpNumber: PRD2083815)
- Maximum Dose
- 40 mmol/kg
- Investigational Product Name
- Panodil 500 mg tabletter.
- Active Substance
- PARACETAMOL
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorised (authorisationCountryCode: NO, euMpNumber: PRD1648887)
- Maximum Dose
- 4 g
- Combination Treatment
- Yes
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